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BioSpace - FDA’s Gottlieb Presents Approach to Real-World Evidence in Clinical Trials

Real-world evidence (RWE) or real-world data (RWD) relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. Speaking yesterday at the Bipartisan Policy Center conference, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb laid out the FDA’s new framework for dealing with RWE and RWD.

 

BioCentury - Lung-MAP Expands to Include All Advanced NSCLC Patients

SWOG's Lung Cancer Master Protocol (Lung-MAP) precision medicine trial is implementing new protocols and expanding to include all advanced stage non-small cell lung cancer patients, moving beyond its initial population of advanced stage squamous cell lung cancer. The new population of patients in Lung-MAP comprises about 85% of all lung cancer diagnoses in the U.S., according to SWOG.

 

Healio - Lung-MAP expands to include all patients with non-small cell lung cancer

The Lung Cancer Master Protocol, or Lung-MAP, will expand to include all patients diagnosed with non-small cell lung cancer.

 

Lung-MAP — the first large-scale precision medicine lung cancer trial backed by the NCI — is supported by a partnership with NCI’s National Clinical Trials Network, SWOG Cancer Research Network, Friends of Cancer Research, the Foundation for the National Institutes of Health, Foundation Medicine, pharmaceutical companies and lung cancer advocacy organizations.

OncLive - NCI Moves to Expand Clinical Trial Eligibility Criteria

In an effort to ensure that study participants are more reflective of real-world populations, the National Cancer Institute (NCI) has revised its clinical trial protocols to expand access for previously excluded patients. The revisions affect potential participants with preexisting conditions in 5 categories: those with brain metastases, prior and current malignancies, HIV and hepatitis infection, and organ dysfunction, as well as patients under the age of 18 years.

 

Cure Today - Comorbidities Associated with Lower Clinical Trial Participation

Patients with cancer who also have other health issues are less likely to participate in a clinical trial, potentially leaving gaps in understanding how drugs may affect individuals with certain comorbidities, according to recent research published in JAMA Oncology.

 

Oncology Nurse Advisor - Modernizing Eligibility Criteria Could Increase Access to, Participation in Clinical Trials

Presence of comorbidities is associated with fewer patient-physician discussions regarding clinical trials, with fewer offers made and less patient participation, according to a report published in JAMA Oncology. Updating eligibility criteria would increase access to new treatments in trials.

 

Medscape - Clinical Trials Too Often Exclude 'Real-World' Cancer Patients

Unnecessarily restrictive criteria for clinical trial participation excluding those with comorbidities excludes many "real-world" cancer patients and prevents them from potentially benefiting from new treatments, say cancer researchers.

 

Modernizing clinical trial eligibility criteria would significantly expand the pool of patients who could participate in such trials across a variety of cancers, they suggest.

 

These comments come from an article published online January 10 in JAMA Oncology.

 

GenomeWeb - Tumor Mutation Burden Predicts Immunotherapy Benefit Across Cancers, Though Cutoffs Differ

Cancer patients with high tumor mutational burden who were treated with immunotherapy tended to live longer than those with fewer mutations, researchers at Memorial Sloan Kettering Cancer Center reported in Nature Genetics this week.

 

American Journal of Managed Care - Comorbidities Impede Clinical Trial Participation Among Patients With Cancer

Clinical trial participation is crucial for drug development, but it’s estimated that just 5% of patients participate in clinical trials. While institutional factors, such as lack of a locally available trial, play the largest role, patient characteristics also pose barriers to participation. According to a study published in JAMA Oncology, patients with comorbidities are less likely to have clinical trial discussions with their physicians, have trials offered to them, and participate in them.

 

MedPage Today - Relax Comorbidity Criteria in Cancer Trials?

As efforts are being made to improve enrollment in cancer trials, a new study found that physicians were less likely to even discuss or offer clinical trial participation when patients had comorbidities.

 

Among over 5,000 cancer patients surveyed, 37.2% of those with at least one comorbid condition had discussions about clinical trials compared with 44.1% of those with no comorbidities (OR 0.86, 95% CI 0.75-0.97, P=0.02), reported Joseph M. Unger, PhD, of Fred Hutchinson Cancer Research Center in Seattle, and colleagues.

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